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CEFADROXIL از شرکت ORCHID HLTHCARE

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CEFADROXIL از شرکت ORCHID HLTHCARE

Abbreviated New Drug Application (ANDA): 065307

Company: ORCHID HLTHCARE

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription

AB

No No
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription

AB

No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/16/2006 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
11/17/2008 SUPPL-3 Labeling

Label is not available on this site.

08/18/2008 SUPPL-2 Labeling

Label is not available on this site.

02/25/2008 SUPPL-1 Labeling

Label is not available on this site.

CEFADROXIL

FOR SUSPENSION;ORAL; EQ 250MG BASE/5ML

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065349 AUROBINDO
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 091036 HIKMA PHARMS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065396 LUPIN
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 250MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065307 ORCHID HLTHCARE

FOR SUSPENSION;ORAL; EQ 500MG BASE/5ML

TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065349 AUROBINDO
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 091036 HIKMA PHARMS
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065396 LUPIN
CEFADROXIL CEFADROXIL/CEFADROXIL HEMIHYDRATE EQ 500MG BASE/5ML FOR SUSPENSION;ORAL Prescription No AB 065307 ORCHID HLTHCARE
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